GORE® Cardioform ASD Occluder experience in transcatheter closure of complex atrial septal defects

Objective To evaluate the GORE (R) Cardioform ASD Occluder (GCO) (WL Gore & Associates, Flagstaff, AZ) device for complex atrial septal defects (ASD) closure. Background Transcatheter ASD closure is still challenging in complex clinical/anatomic settings. This study evaluated the results of GCO in closure of complex ASD in a tertiary referral center. Methods Between January 2020 and March 2021, 72 patients with significant ASD were submitted to transcatheter closure with GCO at our Institution. Based on clinical/anatomic characteristics, they were classified as complex (n = 36, Group I) or simple (n = 36, Group II). We considered as complex, defects with rim deficiency (< 5 mm) other than antero-superior, relatively large (diameter/patient weight > 1.2 or diameter/patient BSA > 20 mm/m(2)) or within a multifenestrated septum. Procedure results and early outcome were compared between the groups. Results Absolute and relative ASD size (20 +/- 4 vs. 15 +/- 3 mm, p < 0.0001; 0.9 +/- 0.3 vs. 0.4 +/- 0.2 mm/kg, p < 0.0001; 23 +/- 7 vs. 12 +/- 5 mm/m(2), p < 0.0001), QP/QS (2.0 +/- 0.8 vs. 1.4 +/- 0.3, p < 0.001), procedure and fluoroscopy times (73 +/- 36 vs. 43 +/- 21 min, p < 0.0001; 16 +/- 9 vs. 9 +/- 4 min, p < 0.0001, procedure feasibility (94.4 vs. 100%, p < 0.0001) and overall complication rate (13.9 vs. 0%, p < 0.0001) were significantly different between the groups. Successful closure of surgical ASDs was achieved in 92% of cases. Complete closure at last follow-up evaluation did not significantly differ between the groups (97.1 vs. 100%, p = NS), as was wireframe fractures rate (49.1% in the overall population), without clinical, EKG and echocardiographic consequences. Conclusions Percutaneous treatment with GCO device is effective and safe in high percentage of complex ASDs.

Automated summary

The study evaluated the effectiveness and safety of the GORE Cardioform ASD Occluder in closing complex ASDs at a tertiary referral center, showing that the device is effective and safe for a high percentage of complex ASDs.